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KPI-121 1% dosed

Phase 3

Post Surgical Ocular Inflammation and Pain | Small molecule | Pain |KALA BIO, Inc.|Last Updated: Dec 16, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment520

FDA Designations

No designations recorded

Clinical trial landscape

KPI-121 1% dosed · 1 trial · 1 indication

Phase 3 1
NCT02793817Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and PainPost Surgical Ocular Inflammation and Pain
COMPLETED520 Analytics
PHASE3COMPLETED
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Post Surgical Ocular Inflammation and PainUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
PurposeTREATMENT

Interventions

NameTypeDescription
KPI-121 1% Ophthalmic Suspension dosed BIDDRUG -
Vehicle of KPI-121 Ophthalmic Suspension dosed BIDDRUG -
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Frequently asked questions about KPI-121 1% dosed

What is KPI-121 1% dosed used for?

KPI-121 1% dosed is an investigational small molecule being developed for the treatment of post-surgical ocular inflammation and pain. It is intended to address inflammation and pain following eye surgery. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes KPI-121 1% dosed?

KPI-121 1% dosed is being developed by KALA BIO, Inc., a biopharmaceutical company. KALA BIO, Inc. is publicly traded under the ticker symbol KALA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for post-surgical ocular inflammation and pain.

What phase is KPI-121 1% dosed in?

KPI-121 1% dosed is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 3 trial has been completed, and the drug remains under investigation for post-surgical ocular inflammation and pain.

What clinical trials is KPI-121 1% dosed in?

KPI-121 1% dosed has one completed Phase 3 clinical trial with the identifier NCT02793817. The trial, titled "Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain," enrolled 520 participants in the United States. The study was randomized and double-blind, though it was uncontrolled.

Is KPI-121 1% dosed FDA approved?

KPI-121 1% dosed is not FDA approved. It is an investigational drug currently in clinical development for post-surgical ocular inflammation and pain. A Phase 3 clinical trial has been completed, but the drug has not received regulatory approval. It remains under investigation for safety and efficacy.